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Hepatitis C, ChronicPhase 1NCT01907724

Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)

A Phase 1 study testing IDX719, Simeprevir and TMC647055 in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed. Read more about this study

Who is it for?
Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
IDX719, Simeprevir and TMC647055
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
No sites listed yet
Study dates
May 2013to Aug 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug
  • Male participants agree not to donate sperm from Day -1 through 90 days after the last dose of study drug

Who cannot join

  • Is pregnant or breastfeeding
  • Has another clinically significant medical conditions or laboratory abnormality(s)

About this study

Official title: A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Subjects

The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.

Being tested
IDX719, Simeprevir, TMC647055, RTV
Keywords
Chronic hepatitis C, Hepatitis C virus, HCV
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDX719Drug

    IDX719 will be supplied as a 50 mg tablet for oral administration.

  • SimeprevirDrug

    Also called Olysio™

    Simeprevir will be supplied as 75 mg capsules for oral administration.

  • TMC647055Drug

    TMC647055 will be supplied as 150 mg capsules for oral administration.

  • RTVDrug

    Also called Norvir™

    RTV will be supplied as 80 mg/mL solution for oral administration.

Study groups in NCT01907724
Study groupRoleWhat they receive
IDX719 + RTVExperimentalParticipants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
Receives: Drug: IDX719; Drug: Simeprevir; Drug: TMC647055; Drug: RTV
Simeprevir/TMC647055 + RTVExperimentalParticipants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
Receives: Drug: IDX719; Drug: Simeprevir; Drug: TMC647055; Drug: RTV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observed maximum plasma drug concentration (Cmax)

    Measured: Up to 14 days

  2. Time to maximum concentration (Tmax)

    Measured: Up to 14 days

  3. Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)

    Measured: Up to 14 days

  4. Predose trough concentration (Ctrough)

    Measured: Up to 14 days

  5. Apparent terminal elimination rate constant

    Measured: Up to 14 days

  6. Observed terminal half-life (T1/2)

    Measured: Up to 14 days

Secondary outcomes (3)

  1. Percentage of participants experiencing serious adverse events (SAEs)

    Measured: Up to 28 days

  2. Percentage of participants experiencing adverse events (AEs)

    Measured: Up to 28 days

  3. Percentage of participants with Grade 1-4 laboratory abnormalities

    Measured: Up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01907724
Sponsor's protocol ID
1894-007
Other IDs
IDX-06A-007
Status last verified
Jan 2016
First submitted
4 Jun 2013
Last updated
26 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IDX719, Simeprevir and TMC647055 in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observed maximum plasma drug concentration (Cmax) (time frame: Up to 14 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01907724.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2016.

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